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CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase1)

Primary Purpose

Muscle Spasticity

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CORETOX®
BOTOX®
Sponsored by
Medy-Tox
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Spasticity

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients ≥ 19 years

    • 6 months since the last stroke
    • 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of elbow flexor and finger flexor as measured on MAS(0 to 4)
  • Informed consent has been obtained

Exclusion Criteria:

  • Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
  • History(within 4 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection or surgery in the target limb
  • History(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb
  • Fixed joint/muscle contracture
  • Severe atrophy
  • Concurrent treatment with an intrathecal baclofen
  • Patients who have bleeding tendency or taking anti-coagulant
  • Dysphagia and Breathing Difficulties
  • History(within 4 months of screening visit) Planned(during study period) treatment with Botulinum Toxin
  • Known allergy or sensitivity to study medication or its components
  • Concurrent or planed Muscle relaxants and/or benzodiazepine medication If patient has taken these medication stable from one month before screening and no treatment changes are not planned during the study, participation is allowed.
  • Current Physical, occupational, Splinting therapy These therapy regimens will be permitted if they have been stable in the one month before screening; no treatment and no changes are planned during the study.
  • Patient who are participating in other clinical trials at the screening
  • Females who are pregnant, breastfeeding, or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of contraception.
  • Patients who are not eligible for this study at the discretion of the investigator.

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CORETOX®

BOTOX®

Arm Description

Outcomes

Primary Outcome Measures

Modified Ashworth Scale of wrist flexor
Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS (Modified Ashworth Scale) Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)

Secondary Outcome Measures

Modified Ashworth Scale of elbow and finger flexor
Change from baseline at week 4 for elbow flexor and finger flexor muscle tone as measured on MAS Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)
Modified Ashworth Scale of wrist, elbow and finger flexor
Change from baseline at week 8, 12 for wrist flexor, elbow flexor and finger flexor muscle tone as measured on MAS Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)
Modified Ashworth Scale of wrist, elbow and finger flexor
The responder rate of wrist, elbow, and finger flexor tone at week 4, 8 and 12 if the responder rate is defined as at least 1-point decrease in MAS score after IP administration. Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)

Full Information

First Posted
December 5, 2021
Last Updated
December 21, 2021
Sponsor
Medy-Tox
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1. Study Identification

Unique Protocol Identification Number
NCT05164003
Brief Title
CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase1)
Official Title
A Randomized, Double-blind, Active Drug Controlled, Multi-Center, Phase I/III Clinical Trial to Evaluate the Efficacy and Safety of CORETOX® in Treatment of Post Stroke Upper Limb Spasticity
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
September 29, 2017 (Actual)
Study Completion Date
September 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medy-Tox

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and pharmacodynamic of CORETOX® in the treatment of post-stroke upper limb spasticity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CORETOX®
Arm Type
Experimental
Arm Title
BOTOX®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CORETOX®
Intervention Description
Up to a total of 360U of the IP was allowed to be injected at three flexors; wrist, elbow and finger.
Intervention Type
Drug
Intervention Name(s)
BOTOX®
Intervention Description
Up to a total of 360U of the comparator was allowed to be injected at three flexors; wrist, elbow and finger.
Primary Outcome Measure Information:
Title
Modified Ashworth Scale of wrist flexor
Description
Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS (Modified Ashworth Scale) Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale of elbow and finger flexor
Description
Change from baseline at week 4 for elbow flexor and finger flexor muscle tone as measured on MAS Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)
Time Frame
4 weeks after the injection
Title
Modified Ashworth Scale of wrist, elbow and finger flexor
Description
Change from baseline at week 8, 12 for wrist flexor, elbow flexor and finger flexor muscle tone as measured on MAS Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)
Time Frame
8 and 12 weeks after the injection
Title
Modified Ashworth Scale of wrist, elbow and finger flexor
Description
The responder rate of wrist, elbow, and finger flexor tone at week 4, 8 and 12 if the responder rate is defined as at least 1-point decrease in MAS score after IP administration. Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)
Time Frame
4, 8 and 12 weeks after the injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients ≥ 19 years 6 months since the last stroke 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of elbow flexor and finger flexor as measured on MAS(0 to 4) Informed consent has been obtained Exclusion Criteria: Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis History(within 4 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection or surgery in the target limb History(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb Fixed joint/muscle contracture Severe atrophy Concurrent treatment with an intrathecal baclofen Patients who have bleeding tendency or taking anti-coagulant Dysphagia and Breathing Difficulties History(within 4 months of screening visit) Planned(during study period) treatment with Botulinum Toxin Known allergy or sensitivity to study medication or its components Concurrent or planed Muscle relaxants and/or benzodiazepine medication If patient has taken these medication stable from one month before screening and no treatment changes are not planned during the study, participation is allowed. Current Physical, occupational, Splinting therapy These therapy regimens will be permitted if they have been stable in the one month before screening; no treatment and no changes are planned during the study. Patient who are participating in other clinical trials at the screening Females who are pregnant, breastfeeding, or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of contraception. Patients who are not eligible for this study at the discretion of the investigator.
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase1)

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